What makes your study a clinical trial?

To qualify as a clinical trial, your study must:
• be conducted on human participants. (If your study involves animals, you should contact AWERB.Secretary@manchester.ac.uk.)
• investigate an intervention. The study treats or diagnoses its subjects with a drug, medical device, gene-therapy or other medical intervention. (If your study is not an interventional trial, then it is likely an observational study, e.g. a case-control, cross-sectional, or cohort study. Please contact FBMHethics@manchester.ac.uk about observational studies.)
• look for an effect. The study must collect data on measurements chosen during the trial design.
• compare the intervention to a control. Participants are assigned to either the intervention or a control—no treatment, a placebo, or the best available standard therapy—and outcomes in both groups are then compared.
be prospective. Subjects must be studied forward in time, which means retrospective studies are not classed as clinical trials. (If your study is retrospective please contact FBMHethics@manchester.ac.uk.)

MHRA Clinical Trial Algorithm

If you are still not sure whether your study is a clinical trial, the Medicines and Healthcare Products Regulatory Agency (MHRA) has devised an algorithm to help you make this decision. As well as helping you decide if your study is a clinical trial, this algorithm also helps you determine what type of clinical trial it might be. Your clinical trial may be a Clinical Investigation of an Investigational Medicinal Product (CTIMP), an Advanced Therapy Medicinal Products (ATMP), a clinical investigation/trial of a medical device (MD), or a non-CTIMP (i.e. investigate a diagnostic tool or treatment that does not qualify as a CTIMP, ATMP, or MD / uses drugs, but not in an investigational capacity, and measures a clinical outcome / uses drugs in an investigational capacity but not to measure a clinical outcome)

If you are still in doubt, please contact us at clinicaltrials@manchester.ac.uk.